Michael Tappin QC appeared as lead counsel for Sandoz in proceedings brought with Teva to revoke a patent owned by Bristol-Myers Squibb (“BMS”). BMS counterclaimed for infringement, which, in the event that the patent was found to be valid, Sandoz and Teva admitted.
The patent related to the compound apixaban sold by BMS under the name Eliquis and used for thromboembolic disorders. Its use in therapy depends on its activity as a factor Xa inhibitor. Sandoz and Teva alleged that the patent did not make it plausible that apixaban would have any useful factor Xa inhibitory activity and/or would be useful in therapy. It was, therefore, alleged that the patent was Agrevo obvious and/or insufficient. The patent was also alleged to be obvious in that it made no technical contribution over an earlier publication. Teva ran a separate obviousness attack based on the claims in the patent exceeding its technical contribution.
Meade J held that the patent was invalid. The judge conducted a detailed review of the law on obviousness and insufficiency in relation to plausibility, referring to both UK and EPO authorities. He held that the patent did not make it plausible that apixaban would have any useful degree of factor Xa binding. Even if the patent did make any factor Xa binding plausible, it was not plausible that it would be useful in therapy or in any potential non-therapeutic uses relied on by BMS. BMS’s proposed amendment to the patent would not cure the finding of invalidity.